PMA P020009S117
- Device
- EXPRESS 2 MONORAIL AND OTW CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S117
- Product code
- MAF
- Decision date
- 2014-03-19
- Generic name
- STENT, CORONARY
- Approval order statement
- ELIMINATE THE POUCH SEAL PULL TEST INSPECTION IN THE MANUAL FINAL PACKAGING OPERATION.
Current openFDA PMA Record#
- Device
- EXPRESS 2 MONORAIL AND OTW CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S117
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2014-03-19
- Decision code
- OK30
- Date received
- 2014-02-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ELIMINATE THE POUCH SEAL PULL TEST INSPECTION IN THE MANUAL FINAL PACKAGING OPERATION.